Spine SurgeryNCT00696501
Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns
An observational study of Spine Surgery and Neuromuscular Mapping, run by Lahey Clinic at 1 site in United States.
Trial summary
The purpose of this study is to collect data while monitoring muscles and nerves during spine surgery. The data being collected and analyzed will be used to learn more about how the body's nerves and muscles are distributed and develop a map of human muscle innervation patterns. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spine Surgery, Neuromuscular Mapping, Neurodiagnostics
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All neurosurgical patients will be screened for potential eligibility from the Neurosurgery Department's Clinical and operative schedules.
Who may be able to join
- Patients undergoing either cervical or lumbar cord procedures at Lahey Clinic and during which the surgeon has requested intra-operative neurophysiologic monitoring.
- Surgery performed by a neurosurgeon
- Participant must be ≥ 18 years of age or ≤ 85 years of age
- Participant, or legally authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the Lahey Clinic IRB
Who cannot join
- Past medical history significant for any of the following:
- Peripheral Neuropathy
- Patients with Diabetes Mellitus
- Neuromuscular disease that would interfere with intra-operative recordings
- The Investigator determines that the patient should not be included in the study for reason(s) not already specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Neurosurgery Department, Lahey Clinic, Inc.
Burlington, Massachusetts, 01805
About this study
The purpose of this study is to collect data while monitoring muscles and nerves during spine surgery. The data being collected and analyzed will be used to learn more about how the body's nerves and muscles are distributed and develop a map of human muscle innervation patterns.
Read the detailed description
In this large scale study it is proposed to examine root-to-muscle innervation directly, using the standard Intra-Operative Monitoring procedures during scheduled cervical and lumbar spinal surgeries. The study would directly map muscle and sensory distributions of nerve root innervations with no additional risk to patients.
- Conditions
- Spine Surgery, Neuromuscular Mapping, Neurodiagnostics
- Keywords
- Neuromuscular mapping, Spinal surgery, Neurodiagnostics, Segmental root innervation, Dermatomal innervation, Myotomal innervation, Nerve roots, Sensory, Signs and Symptoms
- Medical subject headings
- Signs and Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
Build a database of spinal nerve root innervation utilizing direct nerve root stimulation
Measured: Data collected during surgery and a 30 day post-op visit
Secondary outcomes (1)
Compare clinical symptoms of the patient to the direct muscle activation via spinal nerve root stimulation
Measured: Data collected during surgery and a 30 day post-op visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study startMay 2006
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: One of the investigators left the Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Subu N. Magge, M.D., Principal investigator, Lahey Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696501
- Sponsor's protocol ID
- 2006-039
- Status last verified
- Aug 2017
- First submitted
- 10 Jun 2008
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Dykes RW, Terzis JK. Spinal nerve distributions in the upper limb: the organization of the dermatome and afferent myotome. Philos Trans R Soc Lond B Biol Sci. 1981 Aug 12;293(1070):509-54. doi: 10.1098/rstb.1981.0083.
PubMed 6115429Tsao BE, Levin KH, Bodner RA. Comparison of surgical and electrodiagnostic findings in single root lumbosacral radiculopathies. Muscle Nerve. 2003 Jan;27(1):60-4. doi: 10.1002/mus.10291.
PubMed 12508296Levin KH, Maggiano HJ, Wilbourn AJ. Cervical radiculopathies: comparison of surgical and EMG localization of single-root lesions. Neurology. 1996 Apr;46(4):1022-5. doi: 10.1212/wnl.46.4.1022.
PubMed 8780083Moller AR. Intraoperative neurophysiologic monitoring. Am J Otol. 1995 Jan;16(1):115-7. No abstract available.
PubMed 8579167Bose B, Sestokas AK, Schwartz DM. Neurophysiological monitoring of spinal cord function during instrumented anterior cervical fusion. Spine J. 2004 Mar-Apr;4(2):202-7. doi: 10.1016/j.spinee.2003.06.001.
PubMed 15016399MacDonald DB. Safety of intraoperative transcranial electrical stimulation motor evoked potential monitoring. J Clin Neurophysiol. 2002 Oct;19(5):416-29. doi: 10.1097/00004691-200210000-00005.
PubMed 12477987Deletis, V. (2002), Intraoperative Neurophysiology and Methodologies Used to Monitor the Functional Integrity of the Motor System
Chiappa, K.H. (1997) Evoked Potentials in Clinical Medicine
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Stimulation Of Spinal Nerve Roots To Determine Sensory And Motor Innervation Patterns
- ClinicalTrials.gov ID
- NCT00696501
- Acronym / sponsor ID
- 2006-039
- Conditions
- Spine Surgery, Neuromuscular Mapping, Neurodiagnostics
- Keywords
- Neuromuscular mapping, Spinal surgery, Neurodiagnostics, Segmental root innervation, Dermatomal innervation, Myotomal innervation, Nerve roots, Sensory
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: One of the investigators left the Institution
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect data while monitoring muscles and nerves during spine surgery. The data being collected and analyzed will be used to learn more about how the body's nerves and muscles are distributed and develop a map of human muscle innervation patterns.
Detailed description
In this large scale study it is proposed to examine root-to-muscle innervation directly, using the standard Intra-Operative Monitoring procedures during scheduled cervical and lumbar spinal surgeries. The study would directly map muscle and sensory distributions of nerve root innervations with no additional risk to patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All neurosurgical patients will be screened for potential eligibility from the Neurosurgery Department's Clinical and operative schedules.
Key inclusion criteria (4 listed)
- Patients undergoing either cervical or lumbar cord procedures at Lahey Clinic and during which the surgeon has requested intra-operative neurophysiologic monitoring.
- Surgery performed by a neurosurgeon
- Participant must be ≥ 18 years of age or ≤ 85 years of age
- Participant, or legally authorized representative, has been informed of the nature of the study and has provided written informed consent, approved by the Lahey Clinic IRB
Key exclusion criteria (5 listed)
- Peripheral Neuropathy
- Patients with Diabetes Mellitus
- Neuromuscular disease that would interfere with intra-operative recordings
- The Investigator determines that the patient should not be included in the study for reason(s) not already specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Build a database of spinal nerve root innervation utilizing direct nerve root stimulation
Time frame: Data collected during surgery and a 30 day post-op visit
1 secondary outcome
Compare clinical symptoms of the patient to the direct muscle activation via spinal nerve root stimulation
Time frame: Data collected during surgery and a 30 day post-op visit
Results and safety
The study was stopped early (reason given: One of the investigators left the Institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Background: PubMed 6115429Dykes RW, Terzis JK. Spinal nerve distributions in the upper limb: the organization of the dermatome and afferent myotome. Philos Trans R Soc Lond B Biol Sci. 1981 Aug 12;293(1070):509-54. doi: 10.1098/rstb.1981.0083.
- Background: PubMed 12508296Tsao BE, Levin KH, Bodner RA. Comparison of surgical and electrodiagnostic findings in single root lumbosacral radiculopathies. Muscle Nerve. 2003 Jan;27(1):60-4. doi: 10.1002/mus.10291.
- Background: PubMed 8780083Levin KH, Maggiano HJ, Wilbourn AJ. Cervical radiculopathies: comparison of surgical and EMG localization of single-root lesions. Neurology. 1996 Apr;46(4):1022-5. doi: 10.1212/wnl.46.4.1022.
- Background: PubMed 8579167Moller AR. Intraoperative neurophysiologic monitoring. Am J Otol. 1995 Jan;16(1):115-7. No abstract available.
- Background: PubMed 15016399Bose B, Sestokas AK, Schwartz DM. Neurophysiological monitoring of spinal cord function during instrumented anterior cervical fusion. Spine J. 2004 Mar-Apr;4(2):202-7. doi: 10.1016/j.spinee.2003.06.001.
- Background: PubMed 12477987MacDonald DB. Safety of intraoperative transcranial electrical stimulation motor evoked potential monitoring. J Clin Neurophysiol. 2002 Oct;19(5):416-29. doi: 10.1097/00004691-200210000-00005.
- BackgroundDeletis, V. (2002), Intraoperative Neurophysiology and Methodologies Used to Monitor the Functional Integrity of the Motor System
- BackgroundChiappa, K.H. (1997) Evoked Potentials in Clinical Medicine
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subu N. Magge, M.D. principal investigator
Lahey Clinic, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Surgery and Neuromuscular Mapping, run by Lahey Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: One of the investigators left the Institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Build a database of spinal nerve root innervation utilizing direct nerve root stimulation (time frame: Data collected during surgery and a 30 day post-op visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00696501, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.